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Non-Operative Management Approaches for Urinary Incontinence

N/A

Recruiting

Led By Goutham Rao, MD

Research Sponsored by Adonis Hijaz, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥ 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months (wave 1)

Awards & highlights

Study Summary

This trial is testing different approaches to improve diagnosis and non-operative management of urinary incontinence in women.

Who is the study for?

This trial is for women over 18 who are experiencing urinary incontinence and have visited the University Hospitals Cleveland Primary Care Institute. Participants should score at least 1 on a specific questionnaire about incontinence.Check my eligibility

What is being tested?

The EMPOWER study aims to enhance the diagnosis and non-surgical treatment of urinary incontinence among women, using patient education, nurse-led guidance, and a ChatBot to provide support.See study design

What are the potential side effects?

Since this trial focuses on educational interventions rather than medications or surgeries, side effects are not typical but may include discomfort from discussing personal health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months (wave 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months (wave 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months (wave 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in patients' UI symptoms as measured by International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

Urinary Incontinence

Secondary outcome measures

Change in impact of UI on patients' quality of life as measured by the ICIQ-LUTSqol

Change in overactive bladder symptom severity as measured by the OABSS

Change in patient empowerment as measured by a patient survey

+10 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm 3Experimental Treatment3 Interventions

Patient Education + Nurse Navigation + ChatBot

Group II: Arm 2Experimental Treatment2 Interventions

Patient Education + Nurse Navigation

Group III: Arm 1Experimental Treatment1 Intervention

Patient Education

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Adonis Hijaz, MDLead Sponsor

Goutham Rao, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Media Library

Arm 1 Clinical Trial Eligibility Overview. Trial Name: NCT05515198 — N/A

Urinary Incontinence Research Study Groups: Arm 1, Arm 2, Arm 3

Urinary Incontinence Clinical Trial 2023: Arm 1 Highlights & Side Effects. Trial Name: NCT05515198 — N/A

Arm 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515198 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the purported outcomes of this clinical experiment?

"The primary aim of this clinical trial, monitored over the baseline and 2nd and 6th month (all waves) is to assess patients' UI symptoms through International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Furthermore, secondary outcomes include a change in OAB symptom severity evaluated by Overactive Bladder Symptom Score (OABSS), urinary symptoms measured with Urinary Distress Inventory-6(UDI-6), as well as number of practices that retain an intervention for UI management assessed via practice survey."

Answered by AI

Are there any remaining entry slots available for the participants of this clinical trial?

"Correct. Records hosted on clinicaltrials.gov verifies that this medical study, which was first listed on September 6th 2022, is actively seeking applicants. Approximately 10000 participants need to be recruited from 1 research facilities."

Answered by AI

What is the total enrollment for this medical experiment?

"Affirmative. Clinicaltrials.gov has information that points to this research project, which began advertising on September 6th 2022, as still actively recruiting participants. The study is seeking 10000 subjects from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Care for Women With Urinary Incontinence (EMPOWER)

Adonis Hijaz, MD 2022. "Improving Care for Women With Urinary Incontinence (EMPOWER)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05515198.

All > Urinary Incontinence